Quick Facts at a Glance
- Recall Date
- March 11, 2026
- Hazard Level
- HIGH
- Brands
- DEXTROSE, FRESENIUS KABI USA, LLC
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT, ELDERLY
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- DEXTROSE, FRESENIUS KABI USA, LLC
- Product type
- Intravenous (IV) Dextrose Injection
- Model numbers
- Batch# 6402296, Exp Date: 07/31/2026.
- UPC codes
- 65219-456, 65219-464, 65219-458, 65219-460, 65219-462, 65219-456-05, 65219-456-60, 65219-464-05 +7 more
- Sizes
- 50 mL in 100 mL bag
- Sold at
- Unknown
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
March 11, 2026
Reported by FDA DRUG
April 15, 2026
RecallRadar source check
April 22, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Lack of Assurance of Sterility
What You Should Do
Consumers and healthcare providers should stop using this product immediately. Contact Fresenius Kabi USA, LLC or your healthcare provider for guidance. Notification method: Letter
About This Product
5% Dextrose Injection is a sterile IV fluid used to provide calories and fluids. It is commonly used in hospitals for various IV therapies.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Hospitals and clinics may need to quarantine lots, notify patients, and switch to alternative sterile IV solutions.
Practical Guidance
How to identify if yours is affected
- Identify the product by NDC 65219-456-05 or 65219-456-60
- Check Batch 6402296 and Exp 07/31/2026
- Verify 50 mL in a 100 mL freeflex bag packaging
- Review recall letters for facility-specific guidance
Where to find product info
FDA enforcement report D-0435-2026 and Fresenius Kabi recall communications
What timeline to expect
Facility-level recalls typically resolve within weeks; hospitals may implement replacements within 4-8 weeks
If the manufacturer is unresponsive
- Escalate to hospital compliance office
- Contact FDA Consumer Product Safety Commission
- Document all communications
How to prevent similar issues
- Source sterile IV solutions from reputable suppliers
- Verify batch numbers before administration
- Maintain lot segregation and quarantine procedures for recalled lots
- Stay updated with FDA recall notices
Documentation advice
Keep recall letters, batch numbers, and communications with suppliers for records
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Product Details
Product: 5% Dextrose Injection, USP 2.5 g per 50 mL (50 mg per mL). Bag: 50 mL in a 100 mL freeflex bag. NDCs: Unit of Use 65219-456-05; Unit of Sale 65219-456-60. Batch: 6402296. Expiration: 07/31/2026. Sold in the US nationwide, including Alaska and Puerto Rico. Company: Fresenius Kabi USA, LLC. Recall date: 2026-03-11. Status: ACTIVE.
Reported Incidents
No specific incident counts are provided in the notice. The FDA page lists the issue but does not mention injuries or adverse events.
Key Facts
- 5% Dextrose Injection, USP
- 50 mL in a 100 mL freeflex bag
- US nationwide distribution including Alaska and Puerto Rico
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Safety Guide
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